Tag: test method validation

Metrics Supporting Process Performance Qualification (PPQ)

Metrics Supporting Process Performance Qualification (PPQ) Metrics Supporting Process Performance Qualification (PPQ) In the pharmaceutical and biologics industries, the validation of processes is crucial for ensuring product quality and compliance with regulatory expectations. This article provides a comprehensive step-by-step tutorial…

Automation of Data Pulling from SCADA/PLC Systems

Automation of Data Pulling from SCADA/PLC Systems Automation of Data Pulling from SCADA/PLC Systems This article serves as a comprehensive, step-by-step guide for pharmaceutical professionals focused on test method validation within the contexts of Continued Process Verification (CPV). By adhering…

Integration of HVAC Qualification into Aseptic Facility Validation

Integration of HVAC Qualification into Aseptic Facility Validation Integration of HVAC Qualification into Aseptic Facility Validation In the pharmaceutical and biopharmaceutical industries, aseptic processing plays a critical role in ensuring product sterility and patient safety. A key component of aseptic…

Revalidation Practices in EU vs US vs PIC/S Regions

Revalidation Practices in EU vs US vs PIC/S Regions Revalidation Practices in EU vs US vs PIC/S Regions In the pharmaceutical and biologics industry, ensuring the consistency and reliability of processes, equipment, and test methods is of paramount importance. This…

Examples of Risk Control Actions Derived from ICH Q9

Examples of Risk Control Actions Derived from ICH Q9 Examples of Risk Control Actions Derived from ICH Q9 As the pharmaceutical industry continues to evolve, the importance of adhering to rigorous validation processes is paramount. A critical component of this…

Challenges in Method Transfer Across Global Sites

Challenges in Method Transfer Across Global Sites Challenges in Method Transfer Across Global Sites In the highly regulated pharmaceutical and medical device industries, method transfer between global sites poses significant challenges that must be meticulously addressed to ensure compliance with…

Condensate Return System Qualification and Monitoring

Condensate Return System Qualification and Monitoring Condensate Return System Qualification and Monitoring Condensate Return System Qualification and Monitoring – Practical guide for pharma professionals on test method validation with GMP, FDA and EMA compliance. Step 1: Understanding User Requirements Specification…

Common Issues in Blend Uniformity and How to Address Them

Common Issues in Blend Uniformity and How to Address Them Common Issues in Blend Uniformity and How to Address Them Blend uniformity is a critical aspect of pharmaceutical manufacturing, ensuring that active ingredients are consistently distributed throughout a batch. Understanding…

Process Qualification Protocols: Equipment, Utilities & Process Systems

Process Qualification Protocols: Equipment, Utilities & Process Systems Creating Process Qualification Protocols for Equipment, Utilities & Systems in Pharma Stage 2 of pharmaceutical process validation—Process Qualification (PQ)—is the critical phase where designed processes, equipment, and systems are tested under actual…